Kornimate/medical-research-clean huggingface dataset:
assessment of safety of the use of fenfluramine in children with dravet syndrome under 24 months of age

Conditions: Dravet Syndrome (DS); Children Under 2 Years

Summary: dravet syndrome is a genetic epilepsy associated with pathogenic variants in scn1a that codes for nav1.1, a protein necessary for sodium channels. children with dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. this creates some limitations in medication choices for this patient population. recently fenfluramine was approved for use in dravet syndrome for people 2 years and older. randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. additionally, 16% of children treated with fenfluramine were seizure free. fenfluramine is likely to be as effective in children under the age of 2 years. the current study has proposed a treatment protocol to allow access to fenfluramine for children under 24 months of age.


Eligibility criteria:
inclusion criteria: treating physicians must submit a clinical statement of potential benefit to the lead site for review of the multi-pis, which includes patient's gender, age, diagnosis, genetic pathogenic variant, co-morbidities, seizure history, prior and current therapies, response to prior therapies and reason for request. echocardiogram (echo) results must also be submitted to the lead site prior to final approval. patients must be between 12 and 23 months old to be eligible. each subject will be reviewed by the multi-pis to ensure agreement that the subject has dravet syndrome. additional inclusion criteria: 1. scn1a with a known or presumed pathogenic variant or vus with a history of prolonged seizure or a clinical diagnosis of dravet syndrome. 2. failure of at least one anti-seizure medication that is not a sodium channel blocker (lamotrigine, oxcarbazepine, carbamazepine, eslicarbazepine) exclusion criteria: 1. patients with mild or greater mitral valve regurgitation and/or trace or greater aortic valve regurgitation will not be eligible for participation. the clinical statement can be submitted first for initial, conditional approval and then echo results can be submitted at a later date for final approval. 2. patients with failure to thrive will not be eligible for participation as fenfluramine can suppress appetite and has a risk for weight loss. failure to thrive will be evaluated on the following criteria: 1. weight less than the 2nd percentile. 2. lack of weight gain that crosses two or more of the major percentile lines and is not congruent with length. inclusion of patients will be at the sole discretion of the multi-pis based on a majority vote.

Keywords: fenfluramine dravet syndrome children under 2 years
effect of the livestrong at the ymca exercise program on cancer related outcomes in cancer survivors

Conditions: Breast Cancer

Summary: the proposed study is a randomized trial evaluating the impact of the 12-week livestrong exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.

the proposed study is a randomized trial evaluating the impact of the 12-week livestrong exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors. participants will undergo baseline testing at dana-farber or yale, including administration of questionnaires to assess quality of life and the presence of cancer and treatment-related symptoms, fasting blood draw, and evaluation of body composition (using dual energy x-ray absorptiometry (dexa). participants will then take part in the 12-week livestrong program or will be assigned to a wait-list control group. all measurements will be repeated at dana-farber or yale after the 12-week exercise program or control period.

Eligibility criteria:
inclusion criteria: * cancer diagnosis excluding non-melanoma skin cancer * physically able to exercise * able to complete forms and understand instructions in english * agrees to be randomly assigned to either exercise or wait-list control group * willing and able to attend one of the livestrong at the ymca programs for 12 weeks * willing and able to complete the baseline and 3-month clinic visits exclusion criteria: * \> 80 years of age * \< 18 years of age * recent (past 6 months) stroke/myocardial infarction or congestive heart failure/documented ejection fraction \< 40% * plans to undergo a major surgical procedure in the next 6 months * presence of dementia or major psychiatric disease that would preclude participation in a group-based exercise program * pregnant women or women intending to become pregnant

Keywords: body composition exercise survivorship
cpl-01 in the management of postoperative pain after bunionectomy

Conditions: Bunion

Summary: subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive cpl-01 will have less pain and less opioid use than either control arm.

after signing informed consent, subjects will be randomly assigned to receive study drug (either investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. follow-up will then occur at 7 and 30 days afterwards. the hypothesis is that subjects who receive cpl-01 will have less pain and require fewer opioids than subjects in the other two arms.

Eligibility criteria:
inclusion criteria: * ability to sign icf * bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries * bmi ≤ 39 kg/m2 * if biologically female, not pregnant or planning to become pregnant over the study * if biologically male, either sterile or using acceptable form of birth control * be willing and able to complete study procedures exclusion criteria: * has previously undergone unilateral simple bunionectomy. * has a planned concurrent surgical procedure * has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments * has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments. * has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * has history or evidence of impaired liver function (e.g., alanine aminotransferase \[alt\] \> 3 × upper limit of normal \[uln\] or total bilirubin \> 2 × uln), active hepatic disease, or cirrhosis. * has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × uln). * has a history of malignancy in the past year * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months
safety study of the vega uv-a system to treat keratoconus

Conditions: Keratoconus

Summary: the purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (cxl), when used to treat keratoconus.


Eligibility criteria:
inclusion criteria: * 12 years of age or older * having a diagnosis of keratoconus * presence of central or inferior steepening * topography consistent with keratoconus * presence of one or more slit lamp or retinoscopy findings associated with keratoconus * contact lens wearers only:removal of contact lenses for the required period of time * signed written informed consent * willingness and ability to comply with schedule for follow-up visits exclusion criteria: * for keratoconus, a history of previous corneal surgery or the insertion of intacs in the eye to be treated * corneal pachymetry ≤ 400 microns * previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision * a history of chemical injury or delayed epithelial healing in the eye(s) to be treated. * pregnancy (including plan to become pregnant) or lactation during the course of the study * a known sensitivity to study medications * nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests * a condition that, in the investigator's opinion, would interfere with or prolong epithelial healing. * presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
bioequivalence study of clindamycin phosphate topical lotion, 1% in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: the objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of gdc 268 to clindamycin phosphate topical lotion, 1% and to compare the efficacy of these two products to the gdc vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. * must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) and ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) and ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at baseline. * must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period. * women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (upt) at the baseline visit (day 1). * in good general health and free of any other clinically significant disease state or physical condition. * subject has provided written informed consent / assent. exclusion criteria: * subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study. * subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. * subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator. * subject is planning surgery during the study. * subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles. other eligibility criteria not listed above will be reviewed for each prospective subject by the study staff.

Keywords: zits pimples blackheads
ten years follow up of peri-implant surgery

Conditions: Peri-Implantitis

Summary: to report 10-years follow up of patients following the surgical treatment of peri-implantitis and to identify possible risk indicators for the progression of disease during supportive peri-implant therapy.

the data for this retrospective clinical evaluation were collected from the files and radiographs of consecutive patients who had received surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (spt) . between 2007 and 2009, 41 patients with at least 1 implant with peri-implantitis that underwent peri-implant surgery were enrolled in a supportive peri-implant therapy. at the 2-years follow up, two groups could be identified, one "responding group" (17 patients) who did not present any implants with peri-implantitis and a "no-responding group" (22 patients), presenting still peri-implantitis. following the 2-years control visit, 17 patients of the responding group exited the supporting peri-implant therapy at the specialist clinic. they continued the routine controls at their referral clinics while the 22 patients of the no-responding group, continued the scheduled supportive peri-implant therapy (spt) given at the specialist clinic.

Eligibility criteria:
inclusion criteria: - all patients treated with peri-implantitis surgery between 2007 and 2009 using an anti-infective protocol. exclusion criteria: * patients treated with peri-implantitis surgery between 2007 and 2009 using a regenerative protocol at one single implants with peri-implantitis.

Keywords: peri-implantitis surgery treatment outcome risk factors
the impact of the therapeutic virtual reality headset on patient anxiety in the waiting room before flexible bronchoscopy in vigil

Conditions: Bronchial Fibroscopy

Summary: bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination. investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile. a great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. the innovative aspect is to target the patient's waiting time for the examination. waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients.


Eligibility criteria:
inclusion criteria: * adult patients with no age or gender restrictions, seen on an outpatient basis at le mans hospital. * in whom bronchial fibroscopy is indicated. * person affiliated with or benefiting from a social security . * free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research). * patient able and willing to answer questionnaires exclusion criteria: * patient refusing to participate in research * patient who has already undergone bronchoscopy in vigil * patient premedicated for bronchial fibroscopy (anxiolytic, etc.) * patients with a history of epilepsy or psychiatric pathology * patient with vertigo * patient uncooperative, demented or unable to tolerate headgear. * patient under guardianship or curatorship * patients suffering from blindness or deafness * patient with known significant intolerance to screens and/or virtual reality devices * pregnant, nursing or parturient women * unscheduled patients: emergencies, etc. * hospitalized patients

Keywords: virtual reality headset anxiety
pmcf study of the axonics snm system model 5101 (r20)

Conditions: Urinary Urge Incontinence (UUI); Urinary Frequency (UF); Overactive Bladder (OAB)

Summary: post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the axonics snm system ins model 5101.

this post-market clinical follow-up (pmcf) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable axonics snm system ins model 5101 also referred to as r20.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. primary indication of oab (urinary urgency incontinence (uui) / urinary frequency (uf) who are not candidates for, or who have failed conservative treatment 3. willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments exclusion criteria: 1. any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis) 2. any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements 3. previously underwent an external sacral neuromodulation snm trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder) 4. history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 5. a female who is breastfeeding 6. a female with a positive urine pregnancy test
modifying exercise for the copd patient

Conditions: Chronic Obstructive Pulmonary Disease; Arthritis; Pain

Summary: this study will test whether using the biodex biostep semi recumbent elliptical for the chronic obstructive pulmonary disease (copd) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the nustep elliptical. the main outcome of participation will be measured by the number of exercise sessions the patient is able to complete during their pulmonary rehabilitation program. in addition, distance walked in six minutes, dyspnea score, rate of perceived exertion (rpe) score, pain scale index score, and finally, the dartmouth quality of life index (dql) will be assessed in both groups. it is believed that the new machine will provide better overall outcomes compared to the traditional machine.

a prospective cohort study of 25 copd patients with osteoarthritis undergoing an exercise plan in a pulmonary rehab program. patient pain level, clinical outcomes, and ultimately, quality of life outcomes will be assessed in order to assess whether future compliance for copd arthritic patients will occur in an exercise rehabilitation program.

Eligibility criteria:
inclusion criteria: * copd patient * osteoarthritic limitations in upper or lower extremities, or spine * forced expiratory volume (fev)1 less than 70% * forced expiratory volume/forced vital capacity (fev/fvc) ratio less than 70% exclusion criteria: * patients with rheumatoid arthritis

Keywords: chronic obstructive pulmonary disease pain arthritis dyspnea exercise aerobic
a home visit program and perceived care burden

Conditions: Burden

Summary: the aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. a randomized controlled trial was used. the sample consisted of 30 participants in the intervention group and 30 participants in the control group. a home visit program including education and counseling was applied to participants in the intervention group.

the aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. a randomized controlled trial was used. the sample consisted of 30 participants in the intervention group and 30 participants in the control group. a home visit program including education and counseling was applied to participants in the intervention group. a total of five home visits over three months were performed. data were collected by a personal information form, and the zarit caregiver burden scale (zcbs).

Eligibility criteria:
inclusion criteria: * giving care to a patient who was poorly controlled or uncontrolled asthma * giving care to a patient who used an inhaler * age 18 or over * volunteering to participate to the study exclusion criteria: * having a disease with a neuro-psychiatric diagnosis * having vision and hearing problems

Keywords: asthma burden caregiver education home visit
national multicenter interventional study aimed at evaluating the effect on the intestinal microbiota in chronically frail patients who share alterations in intestinal function.

Conditions: Adhd; ALS; Bronchial Asthma

Summary: the objective of the study will be to understand whether a supplementation of the diet with an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber with prebiotic activity combined with a vegetable extract with beneficial activities on carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve absorption, intestinal motility and bowel habit of patients with various pathological conditions, such as als, adhd and bronchial asthma.

clinical survey conducted for research and study purposes, multicenter, focusing on als patients, elderly patients with chronic diseases, and pediatric patients with neurodevelopmental disorders. for each of the diseases treated, patients will be randomized into the two treatment arms (study group, gs; control group, gc) according to a block randomization, with a block size of 4 and an allocation ratio of 1:1. the randomization will be double-blind. * study group or gs: these subjects will be given an active symbiotic preparation consisting of two sticks of 1500mg each and of different colors. * control group or gc:these subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each.

Eligibility criteria:
population 1 : als inclusion criteria: * age at enrollment ≥18 years; * als diagnosis defined or probable according to el escorial criteria (brooks et al., 2000); * respiratory function with fvc% \>50%. exclusion criteria: * subjects unable to give informed consent to the study; * presence of psychiatric disease or severe cognitive impairment; * presence of tracheotomy; presence of severe pre-existing gastrointestinal disease (e.g., ulcerative rectocolitis; crohn's disease). population 2: adhd inclusion criteria: * children between 6 and 16 years old * children with adhd, diagnosed with dsm-5 criteria and in accordance with the protocol shared by the regional adhd reference centers lombardy. exclusion criteria: * presence of intellectual disability (qit\<70), * presence of neurological diseases, epilepsy * presence of genetic syndromes * treatment with drug therapies. co-diagnosis with other psychiatric or neurodevelopmental disorders (i.e. autism, anxiety, depression etc) will not be considered a criterion of exclusion. population 3: bronchial ashtma inclusion criteria: * adults above 18 years of age * diagnosed with bronchial ashtma following ers-ets criteria exclusion criteria: * life expectancy less than 18 months * active respiratory infections * cognitive disorders that prevent participation to the study (mms \<24)